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Supply Quality Engineer
3 months ago
Come join a dynamic Medical Supply manufacturer on the move. O2 is what we do
Leading global manufacturer of oxygen therapy and cardiorespiratory diagnostic equipment, CAIRE Inc. has operations around the globe with its Global Service Headquarters in Ball Ground, GA,
Supplier Quality Engineer II
Classification
Exempt
Job Level
Sr. Individual Contributor to Supervisor
Reports to
Quality Manager
Date
04/02/2024
JOB DESCRIPTION
The Supplier Quality Engineer II follows end to end quality from raw materials to finish goods ensuring supplier quality is managed throughout, while maintaining ISO, FDA and MDSAP standards. The Supplier Quality Engineer II will work directly with suppliers, operations personnel, quality engineers, product engineers, quality technicians and machinists to improve and sustain supplier quality. The Supplier Quality Engineer II will manage supplier quality by performing the following: evaluation of new or existing suppliers through the utilization of PPAP’s, using lean six sigma methodology to improve a supplier’s manufacturing processes, conducting supplier audits, and lastly managing the dispositioning of supplier quality issues through CAIRE’s SCAR and NCR program.
Essential Functions
- and maintain supplier quality relationships while implementing supplier improvement to mitigate risk to CAIRE.
- with the continuous improvement and sustainability of CAIRE’s Supplier Quality Program.
- part of CAIRE’s supplier evaluation and qualification process, conduct PPAPs that include methods such as MSA’s, correlation studies, PFEMA’s, manufacturing control plans, etc., to ensure the establishment of quality approved products before they are received by CAIRE’s manufacturing facilities.
- experience related to different manufacturing processes such as injection molding, die casting, PCBA manufacturing, deep drawing, stamping, CNC machining, etc., visit supplier locations to assist in the resolution of quality problems.
- lean six sigma methodology, investigate supplier quality issues to identify opportunities for improvement as well as assisting suppliers on implementation of those improvements.
- with supplier audits and facilitate pre-assessments and self-surveys.
- SCAR’s, NCR’s and participate in/lead CAPA’s.
- quality projects related to supplier part defects, cost down initiatives and risk reduction.
- and document work instructions, procedures, quality alerts, within the incoming inspection process.
Other duties and responsibilities as assigned.
Competencies
- Ability to communicate effectively with internal customers, cross-functional teammates, regulatory auditors, and suppliers.
- Ability to solve complex problems using sound data, business acumen, and lean six sigma methodology.
- Demonstrate industry knowledge in certified and regulated quality management systems such as ISO13485, ISO9001 or IATF16949, MDSAP, or cGMP.
- Technical ability in trouble shooting, root cause analysis and corrective actions.
- Quality data analysis expertise
Supervisory Responsibility
This position is an individual contributor role but also could carry supervisory responsibility over the QC lab.
Work Environment
This job operates in a professional office environment and manufacturing/distribution environment.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
- Occasional lifting, up to 50 lbs., occasional heavier lifting.
- Occasional pushing, pulling, and handling of materials.
Travel
This position requires up to 25% travel. Some of the travel is international.
Education and Experience
Minimum B.S. degree in engineering or other technical discipline and minimum 5 years of relevant experience.
- Extensive knowledge and experience in different manufacturing processes such as: injection molding, die casting, PCBA manufacturing, deep drawing, stamping, CNC machining, etc.
- Extensive knowledge and experience in PPAP’s and all methods associated with PPAPs such as: MSA’s, correlation studies, PFEMA’s, manufacturing control plans, etc.
- Experience in product quality related data analytics tools such as process capabilities, SPC, pareto, I-MRs, etc.
- Experience in different software solutions such as: Minitab, Tableau, Solidworks, InfinityQS or other SPC software solutions, MasterControl or other EQMS software solutions.
- Experience with FDA-regulated businesses & ISO 13485 and or 9001 Quality Systems practices.
Certified greenbelt or blackbelt in Lean Six Sigma, preferred.
- Quality Engineer (CQE) and/or Certified Supplier Quality Professional (CSQP) and Certified Quality Auditor (CQA).
Additional Eligibility Qualifications
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
